The prevalence of obesity has steadily increased over the years among both genders, all ages, all racial/ethnic groups, all educational levels, and all smoking levels. However, the number of people who are overweight and those exhibiting obesity generally increases with advancing age, then starts to decline among people over 60.
Medical treatment for obesity is met with discouraging results. Approximately 95% of people who begin weight loss programs will regain their weight within two years of their maximal weight loss. In the United States today there are approximately 170,000 primary operations performed for weight loss each year. 86% of operations are restrictive including the Roux-en-Y Gastric Bypass (70%) and the Lap Band procedure (16%). The remainders of operations performed in the United States are malabsorptive procedures such as the biliopancreatic diversion and duodenal switch (12%).
The conventional Roux-en-Y Gastric Bypass is considered the “gold-standard” operation. The components of a successful operation include a small gastric pouch of approximately 30 cubic centimeters (cc), (or the size of an egg), a small pouch outlet of approximately 12 millimeters (mm), (or the size of a dime), connecting to a Roux limb (or small bowel limb) that can be 60 to 200 centimeters (cm) in length. This operation imparts a feeling of early satiety upon the patients causing them to eat significantly less food at one time. Patients must chew their food well, eat slowly and stop when full otherwise they will encounter pain, nausea, and vomiting. In addition to early satiety, foods high in sugar content are restricted due to the potential for a dumping syndrome. Weight loss is immediate with this procedure with maximal weight loss seen in 18-24 months after surgery. Excess body weight loss is estimated to be between 60-80% during this time with improvement or resolution of many weight-related comorbidities.
The Roux-en-Y gastric bypass is traditionally performed through open surgery or with a minimally invasive approach. Operative morbidity and mortality in this population is due to the number of comorbidities present and the magnitude of obesity. Many complications involve the incision, anastomoses, staple lines, or the effects of general anesthesia or long-term problems due to patient non-compliance or self-destructing behaviors which may lead to weight gain and other nutritional derangements.
The second most popular operation performed in the United States and the most common weight loss procedure performed outside of the U.S. is a laparoscopically placed Lap Band. During this procedure an inflatable silicon band is placed around the stomach to create a small gastric pouch (15-20 cc). This operation imparts a feeling of early satiety and portion control to the patients by restricting the amount of food they can eat at one time. The band is adjustable to weight loss and restrictive symptoms and reversible. It is placed laparoscopically with short operating room times, low morbidity, and short hospital stays. However, these patients still require general anesthetic and can have a less than ten percent reoperation rate related to band slippage, erosion, or other mechanical failure. Often, reoperations are done laparoscopically but require general anesthesia as well.
Because of the use of general anesthetic and incisions to effect many conventional gastric bypass or reduction procedures, most patients require some recuperative stay in a hospital. Furthermore, any surgical procedure wherein an incision is made increases the risk of post-operative infection. It would, therefore, be beneficial and desirous to create a method of treating obesity in those persons having an overweight condition effectively without surgery. It would also be advantageous to provide an apparatus which facilitates the gastric reduction in a quick and cost effective manner. It would also be desirable to provide a treatment technique that is reversible in order to return a successful patient to a natural metabolic state.